Resection Electrodes with HF cable

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 28, 2017 Olympus Winter & Ibe GmbH % Dolan Mills Sr. Specialist, Regulatory Affairs Gyrus ACMI. Inc. 136 Turnpike Road Southborough, MA 01772 Re: K171965 > Trade/Device Name: Resection Electrodes with HF cable (WA22702S, WA22703S, WA22706S, WA22707S, WA22721S, WA22723S, WA22732S, WA22751S, WA22755S, WA22760S, WA22737S, WA22738S, WA22739S, WA22766S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S, WA22705S, WA22602S, WA22603S, WA22606S, WA22607S, WA22621S, WA22623S, WA22632S, WA22651S, WA22655S, WA22657S, WA22637S, WA22638S, WA22639S, WA22666S, WA22640S, WA22641S, WA22642S, WA22643S, WA22644S, WA22605S, WA47705S, WA47706S, WA47707S, WA47721S, WA47723S, WA47732S, WA47737S, WA47738S, WA47739S, WA47751S, WA47755S, WA47760S, WA47766S, WA47740S, WA47741S, WA47742S, WA47743S, WA47744S) Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: FAS, FJL, HIH Dated: June 29, 2017 Dear Dolan Mills: Received: June 30, 2017 We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of Image /page/0/Picture/9 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles a stylized caduceus, with three figures or forms intertwined, representing health and human services. {1}------------------------------------------------ devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Charles Viviano -S For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) #### K171965 #### Device Name Resection Electrodes with HF cable (WA22703S, WA22706S, WA22701S, WA2272SS, WA22732S, WA22732S, WA22751S, WA22751S, WA22760S, WA22737S, WA22739S, WA22766S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S, WA22705S, WA22602S, WA22603S, WA22606S, WA22621S, WA22621S, WA22635, WA22651S, WA22655S, WA22657S, WA22637S, WA22638S, WA22639S, WA22666S, WA22640S, WA22641S, WA22642S, WA22644S, WA22605S) #### Indications for Use (Describe) Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." PSC Publishing Services (301) 443-6740 EF Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) #### K171965 Device Name Resection Electrodes with HF cable (WA47705S, WA47707S, WA47721S, WA47723S, WA47732S, WA47737S, WA47738S, WA47739S, WA47751S, WA47755S, WA47760S, WA47740S, WA47740S, WA47741S, WA4742S, WA47743S, WA47744S) Indications for Use (Describe) Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system. Specific indications: - transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis) - lysis of intrauterine septa - endometrial ablation Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # K171965 # 510(k) Summary of Safety and Effectiveness September 22, 2017 ## 1. General Information | Manufacturer: | Olympus Winter & Ibe GmbH<br>Kuehnstr. 61<br>22045 Hamburg<br>Germany<br>Establishment Registration Number: 9610773 | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Correspondent: | Dolan Mills<br>Sr. Specialist, Regulatory Affairs<br>Gyrus ACMI, Inc.<br>136 Turnpike Rd.<br>Southborough, MA 01772-2104<br>Phone: 901.373.0236<br>Fax: 901.373-0220<br>Email: dolan.mills@olympus-osta.com | | Establishment<br>Registration No | 3003790304 | ## 2. Device Identification | Common Name: | - Electrode, Electrosurgical, active, urological | |-------------------------|------------------------------------------------------| | Regulation Number: | 876.4300 | | Classification | - Endoscopic electrosurgical unit and accessories | | Device Class: | II | | Product Code: | FAS / HIH / FJL | | Review Panel: | Gastroenterology / Urology / Obstetrics / Gynecology | | Proprietary/Trade Name: | Resection Electrodes with HF cable | Model numbers: WA22702S, WA22703S, WA22705S, WA22706S, WA22707S, WA22721S, WA22723S, WA22732S, WA22737S, WA22738S, WA22739S, WA22751S, WA22755S, WA22760S, WA22602S, WA22603S, WA22605S, WA22606S, WA22607S, WA22621S, WA22623S, WA22632S, WA22637S, WA22638S, {5}------------------------------------------------ WA22639S, WA22651S, WA22655S, WA22657S, WA22766S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S, WA22666S, WA22640S, WA22641S, WA22642S, WA22643S, WA22644S WA47705S, WA47706S, WA47707S, WA47721S, WA47723S, WA47732S, WA47737S, WA47738S, WA47739S, WA47751S, WA47755S, WA47760S, WA47766S, WA47740S, WA47741S, WA47742S, WA47743S, WA47744S ### 3. Predicate Devices The predicate device was chosen from the following predicate 510(k): | 510(k)<br>No. | Name | Predicate Model No. | Product code /<br>Reg No. | |---------------|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------| | K152092 | Resection Electrodes | WA22302S, WA22503S,<br>WA22306S, WA22507S,<br>WA22521S, WA22523S,<br>WA22332S, WA22351S,<br>WA22355S, WA22557S,<br>WA22537S, WA22538S,<br>WA22539S, WA22566S,<br>WA22540S, WA22541S,<br>WA22542S, WA22543S,<br>WA22544S, WA22305S | FAS / 876.4300<br>FJL / 876.1500<br>HIH / 884.1690 | These predicates have not been subject to a design-related recall. No reference devices were used in this submission. {6}------------------------------------------------ K171965 Page 3 of 6 The Olympus Resection Electrodes with HF cable that are subject to this submission are for application in saline. Depending on the characteristics of electrical current. which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporization and cutting. The subject HF-Resection Electrodes consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft). The accompanying HF cables consist of two lantern plugs on the instrument side and one generator plug on the generator side. The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, bands, rollers, needles or buttons. The electrodes have a shaft diameter of 24 Fr. range in length from 261.8-336.7mm, and range in compatibility with telescopes with a direction of view of 12° - 30°. The design of the HF cable plugs vary depending on which electrosurgical generator they are compatible with. All subject Resection Electrodes are single-use electrodes and are delivered sterile. All subject Resection Electrodes are provided with a single-use, sterile cable to connect the electrode to the generator. ### 5. Indications for Use #### Resection Electrodes with HF cable for use in Urology Article no. : WA22702S. WA22703S. WA22705S. WA22706S. WA22707S. WA22721S, WA22723S, WA22732S, WA22737S, WA22738S, WA22739S, WA22751S, WA22755S, WA22760S, WA22602S, WA22603S, WA22605S, WA22606S, WA22607S, WA22621S, WA22623S, WA22632S, WA22637S, WA22638S, WA22639S, WA22651S, WA22655S, WA22657S, WA22766S, WA22740S, WA22741S, WA22742S, WA22743S, WA22744S, WA22666S, WA22640S, WA22641S, WA22642S, WA22643S, WA22644S Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current. #### Resection Electrodes with HF cable for use in Gynecology Article no. : WA47705S, WA47706S, WA47707S, WA47721S, WA47723S, WA47732S, WA47737S, WA47738S, WA47739S, WA47751S, WA47755S, WA47760S, WA47766S, WA47740S, WA47741S, WA47742S, WA47743S, WA47744S {7}------------------------------------------------ Electrodes with HF-cable are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications. The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in conductive irrigation fluid as part of a resectoscope system. # Specific indications: - transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis) - lysis of intrauterine septa - - endometrial ablation - Although the subject and predicate devices have different indications for use statements, the intended use is the same. The subject device is indicated for gynecologic applications while the predicate device is indicated for urological indications. However, when the decision-making criteria specified in the FDA guidance document, "General/Specific Intended Use," (issued November 4, 1998) are applied, the subject device indications are determined to fall within the scope of the intended use of the predicate device. The specific gynecology indications of the subject device do not represent a different intended use since there is an extensive knowledge base regarding the use of bipolar electrosurgery for gynecological applications, including the disease states listed in the specific gynecologic indications. Therefore, the intended use comparison supports substantial equivalence. # 6. Comparison of Technological characteristics At a high level. the subject and predicate devices are based on the same technological principle with the same elements: - I Resection electrodes consisting of an active (distal) tip, PTFE color code identification at the distal and proximal ends, an insulator between the electrode and electrode tube, a stabilizing (guiding) tube, and arm (shaft) - . HF cables consisting of two lantern plugs on the instrument side and one generator plug on the generator side - I Used in combination with a resectoscope system - 트 Like the predicate electrodes, the subject device resection electrode series features loops, bands, needles, rollers, and a button as active tip shapes - . Resection electrodes utilizing ablation or for resection in saline (dependent on model) - I Respectively identical or similar outer dimensions {8}------------------------------------------------ K171965 Page 5 of 6 - Design changes of the electrodes and cables are minor and do not negatively impact safety or effectiveness of the subject devices - I The same or similar materials in patient contact are used in predicate and subject device and have all been successfully tested for biocompatibility. As stated above, the subject and predicate devices have similar design characteristics and performance specifications, with the exception of the addition of the HF cables. These minor differences, however, do not raise different questions of safety or effectiveness. As demonstrated in the non-clinical testing (e.g., electrical safety, sterilization validation, and package integrity), the different technological characteristics do not affect the safety and effectiveness of the subject devices. ## 7. Performance Data The subject device electrodes, including all patient-contacting materials, are identical in design and manufacturing to the predicate device (K152092). Therefore, the current submission relies on performance testing previously reviewed and deemed acceptable in K152092. ### 8. Electrical safety and electromagnetic compatibility (EMC) Electrical Safety was tested according to | AAMI/ANSI ES 60601-<br>1:2005 + A1:2012, C1:2009<br>and A2:2010 | Medical Electrical Equipment - Part 1.1 General<br>requirements for safety and essential performance. | |------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AAMI/ANSI/IEC 60601-2-2<br>2009 | Medical Electrical Equipment - Part 2-2: Particular<br>Requirements for the Basic Safety And Essential<br>Performance of High Frequency Surgical Equipment<br>and High Frequency Surgical Accessories | | IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: Medical<br>Electrical Equipment - Part 2-18: Particular<br>requirements for the basic safety and essential<br>performance of endoscopic equipment. | Electromagnetic compatibility (EMC) testing according to IEC 60601-1-2 and IEC 60601-2-2 is not applicable to the Resection Electrodes. They do not contain any electrical components that can be influenced by electromagnetic emission as well as electrostatic discharge. From an electromagnetic compatibility point of view, it is a metal bar that cannot be influenced at any time. {9}------------------------------------------------ ## 9. Sterilization and Shelf Life Sterilization is performed according to ISO 11135 and packaging conforms with AAMI ANSI ISO 11607-1:2006. The EtO sterilization cycle has been validated. A sterility assurance level (SAL) of 106 was reached during validation and will be used for routine sterilization in compliance with regulations in force for sterile medical devices. The EtO residuals are within the limits after tunnel degassing time. Shelf Life testing, including package integrity testing in accordance with ISO 11607-1:2006, was conducted to support a shelf life of 3 years for the resection electrodes. ### 10. Conclusion The performance data support the safety and effectiveness of the subject device and demonstrate that the subject device is substantially equivalent to the predicate device. In conclusion, the Resection Electrodes with HF cable are substantially equivalent to the predicate devices.